JP5654584B2 - Correction connector for spine construction - Google Patents

Correction connector for spine construction Download PDF

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Publication number
JP5654584B2
JP5654584B2 JP2012516310A JP2012516310A JP5654584B2 JP 5654584 B2 JP5654584 B2 JP 5654584B2 JP 2012516310 A JP2012516310 A JP 2012516310A JP 2012516310 A JP2012516310 A JP 2012516310A JP 5654584 B2 JP5654584 B2 JP 5654584B2
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extension
bone
configured
extension system
member
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JP2012530550A (en
JP2012530550A5 (en
Inventor
アルバート モンテロ
アルバート モンテロ
オレグ レヴィン
オレグ レヴィン
ウィリアム ストラウスボー
ウィリアム ストラウスボー
トーマス クイーンツィ
トーマス クイーンツィ
Original Assignee
ジンテス ゲゼルシャフト ミット ベシュレンクテル ハフツング
ジンテス ゲゼルシャフト ミット ベシュレンクテル ハフツング
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Priority to US61/187,902 priority
Application filed by ジンテス ゲゼルシャフト ミット ベシュレンクテル ハフツング, ジンテス ゲゼルシャフト ミット ベシュレンクテル ハフツング filed Critical ジンテス ゲゼルシャフト ミット ベシュレンクテル ハフツング
Priority to PCT/US2010/039037 priority patent/WO2010148231A1/en
Publication of JP2012530550A publication Critical patent/JP2012530550A/en
Publication of JP2012530550A5 publication Critical patent/JP2012530550A5/ja
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/7019Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
    • A61B17/7025Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other with a sliding joint
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/7004Longitudinal elements, e.g. rods with a cross-section which varies along its length
    • A61B17/7007Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit around the screw or hook heads
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/7011Longitudinal element being non-straight, e.g. curved, angled or branched
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7032Screws or hooks with U-shaped head or back through which longitudinal rods pass
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7049Connectors, not bearing on the vertebrae, for linking longitudinal elements together

Description

  This application claims priority based on US Provisional Patent Application No. 61 / 187,902, filed Jun. 17, 2009, the entire contents of which are hereby incorporated by reference. .

  The present disclosure relates generally to orthopedics, and more particularly to implants and methods for extending an existing posterior vertebral screw assembly to a further level.

  The options that exist to modify and / or extend the posterior vertebral screw and rod structures in the patient's body are limited. Patients who have previously undergone spinal surgery often develop symptoms at adjacent spinal levels, which often cause pain and require additional surgery. Such additional spinal surgery often requires extending existing hardware structures to one or more additional spinal levels. In such cases, the surgeon may (1) extend the structure using the same hardware as the patient's existing hardware, or (2) handle some of the patient's existing hardware. Leave this without attaching and extend the structure using different hardware, or (3) remove any existing hardware of the patient and include a new spine level to be fitted You must decide whether to replace the hardware. However, these approaches have several drawbacks.

  First, the patient's existing hardware is confirmed via X-ray or fluoroscopy, and if confirmed, the surgeon is still able to obtain the same make and type of hardware in the hospital or on the market You must judge whether or not. The surgeon must also determine whether his skill can modify existing hardware and / or add new hardware. This is because it is more difficult to modify or install existing hardware systems. Based on these decisions, the surgeon will decide to modify with new hardware. Although the surgeon can choose the hardware at his choice, he needs to make a connection between the existing hardware and the new hardware, usually with all existing fixed vertebral bodies, Make an incision long enough to expose the vertebral body to be newly fixed, remove the underlying rod, implant a new screw, and then replace the new rod with the existing implanted rod And inserting into a newly implanted rod. However, there are concerns that such techniques may result in perturbing certain spinal levels that were previously asymptomatic and thus leading to pain that was not previously present. In addition, many vertebral screw systems are not compatible with each other and there are significant limitations on new hardware options for adding to existing structures. Even if the surgeon decides to remove all existing hardware and replace it with new hardware of his choice, he has several vertebral levels that were previously asymptomatic. May be disturbed. Either of these options of adding and replacing hardware is particularly time consuming and the surgeon is unfamiliar with the patient's existing hardware.

  In one embodiment of the invention, the extension system is configured to be functionally coupled to a vertebral implant that is coupled to a vertebra, the implant including a first bone anchor and a first bone anchor. And a first anchor seat. The extension system includes the extension member, the extension member including a main body and an engagement member coupled to the main body. The extension system further comprises a fixture, the fixture configured to couple the extension member to the vertebral implant. The extension system further comprises a second bone anchor that attaches the extension member to the underlying bone disposed adjacent to the vertebra.

  The foregoing summary, as well as the following detailed description of exemplary embodiments of the present application, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the modified connector in accordance with the present application, it is to be understood that the preferred embodiment is illustrated in the drawings, however, the present application is not limited to the detailed arrangement and instrumentalities shown.

1 is a perspective view of a bone fixation assembly configured in accordance with one embodiment, including a plurality of bone fixation elements coupled to a previously implanted spinal fixation rod, each previously fixed to a vertebra. It is shown schematically as 1B is a perspective view of one of the bone fixation elements of FIG. 1A configured in accordance with one embodiment, including an anchor seat, a bone anchor, a collet, and a locking cap. FIG. 1B is a perspective view showing the spinal fixation rod of FIG. 1A. FIG. 1B is a perspective view showing the bone anchor of FIG. 1B. FIG. It is the perspective view which showed the anchor seat part of FIG. 1B. It is the disassembled perspective view which showed the lock cap of FIG. 1B. FIG. 5B is an upper plan view showing the lock cap of FIG. 5A. It is the fracture | rupture side view which showed the lock cap of FIG. 5B. It is the perspective view which showed the collet of FIG. 1B. FIG. 7B is a cutaway side view of the bone fixation element along line 7A-7A of FIG. 1B, with the locking cap removed to show the vertebral screw assembly. FIG. 7B is a cutaway side view similar to FIG. 7A but showing the spinal fixation rod extending through the anchor seat and the lock cap attached to the anchor seat. 8A to 8D are schematic views showing a method of assembling the bone fixation element of FIG. 1A. 1B is a perspective view similar to FIG. 1A, but also showing a plurality of vertebrae above and below the already fixed vertebra. 1 is an exploded view illustrating an extension system configured in accordance with one embodiment. FIG. FIG. 10B is a cross-sectional view illustrating a portion of the extension system of FIG. 10A. FIG. 10B is a perspective view showing the extension system of FIG. 10A coupled to an already implanted bone fixation assembly. FIG. 10B is an enlarged side view of a portion of the extension system showing the extension system of FIG. 10A coupled to an already implanted bone fixation assembly. FIG. 6 is an exploded view showing a cascaded extension system implanted in a plurality of vertebrae. FIG. 11B is a perspective view showing a pair of rows of the cascaded extension system of FIG. 11A implanted in a vertebra. FIG. 7 is a perspective view showing a state in which parallel rows of fixing elements are coupled by a cross bar. FIG. 5 is a perspective view showing a state in which fixation elements connected by a cross bar are implanted into a plurality of vertebrae schematically shown. FIG. 10B is a perspective view of the extension system shown in FIG. 10A, but with an extension member configured in accordance with an alternative embodiment. FIG. 10B is a perspective view of the extension system shown in FIG. 10A, but configured to couple a bone fixation element to an already implanted through-layer screw. FIG. 10B is a perspective view of the pair of extension systems of FIG. 10A, but configured to couple the occipital region to the spinal column. FIG. 14B is another perspective view showing one of the extension systems of FIG. 14A. FIG. 14B is a perspective view showing the extension system of FIG. 14A being coupled between the occipital region and the spinal column. FIG. 14D is another perspective view showing one of the implanted extension systems of FIG. 14C.

  Certain terms are used in the following description for convenience only and should not be construed as limiting in any way. For example, the bone fixation assembly 20 includes one or more bone fixation elements 22 and four bone fixation elements 22a-d as shown in FIG. 1A. As shown in FIG. 1B, each bone anchoring element 22 extends vertically along the axial direction A and extends substantially horizontally along a radial direction R that is perpendicular to the axial direction A. doing. Accordingly, the radial direction R includes a longitudinal direction L and a lateral direction LA extending perpendicularly to the longitudinal direction L. The directional terms “longitudinal” and “lateral” apply to the horizontally extending bone fixation assembly 20 as well, and the directional term “transverse” refers to the vertical direction. Please be aware that it is referenced. The bone anchoring element 22 forms an upper or rear end 21 and a lower or lower end 23, the directional terms “up” and “down” and their derivatives are The direction from 23 to the upper end 21 and the direction from the upper end 21 to the lower end 23 are respectively referred to.

  The terms “inner”, “outer”, “upper”, “lower”, “distal”, and “proximal” refer to the direction toward or away from the geometric center of the bone fixation assembly 20 and its elements. Refer to each. The terms “front”, “back”, “upper”, and “lower” and related terms and / or phrases indicate a preferred position and orientation in the referenced human body and are not meant to be limiting. Furthermore, although the round structures form a diameter as disclosed herein, the round structures can be replaced with alternative structures (eg, polygons), which are not diameters, but alternatives It will be appreciated that a cross-sectional dimension is formed. The term “diameter” in this application is intended to encompass all such alternatives unless specifically stated otherwise. The term includes the words listed above as well as their derivatives and synonyms.

  In this application, the directional terms for the bone fixation assembly 20 and its elements are used in relation to orientation, and the actual orientation for the bone fixation assembly 20 and its elements changes during use. I want to be recognized. For example, although the axial direction is shown as extending along the vertical direction and the radial direction is shown as extending along the horizontal direction, directions encompassing the various directions can be used during use, for example, Depending on the desired orientation of the bone fixation assembly 20 within, it will vary. Accordingly, the directional terminology herein is for non-limiting purposes of clarity and convenience only.

  Referring now to FIG. 1A, the bone fixation assembly 20 includes a plurality of bone fixation elements, eg, bone fixation elements 22a-d, with a spinal fixation rod 24 extending along the longitudinal axis L. Are combined. Each of the bone fixation elements 22a-d includes a bone anchor 30 implanted (eg, screwed) into the corresponding vertebra 27a-d. The bone fixation elements 20a-d may be implanted in the posterior region of the spine, or in any suitable other region of the spine, such as the pedicle or other spinal region. Bone anchor 30 is provided as an overloaded bone anchor with screws, hooks or other structures configured to be attached to the underlying vertebra. Unless stated otherwise, the bone fixation assembly 20 and its elements are made of titanium-aluminum-niobium alloy (TAN), implant grade 316L stainless steel, or any other alternative implant grade material. Made.

  With continued reference to FIG. 1A, bone anchoring elements 22a-d are generally disclosed as being implanted in the vertebral column, eg, the posterior portion of the lumbar, thoracic, or cervical vertebral bodies. In this regard, when bone fixation elements 22a-d are coupled by rod 24, assembly 20 fixes the relative position of the vertebrae (shown schematically as 27a-d). Accordingly, the bone fixation elements 22a-d can be referred to as vertebral implants, the spinal fixation rod 24 can be referred to as a spinal fixation rod, and the bone fixation assembly 20 can be referred to as a vertebral implant. However, it should be appreciated that the bone fixation assembly 20 can also be used to fix other parts of the body, such as joints, long bones, or hands, face, feet, limbs, and skulls.

  As shown in FIG. 2, the spinal column fixing rod 24 is elongated along the longitudinal axis L, and includes a main body 25 having a cylindrical or tubular shape. The longitudinal direction L extends generally in the cranial-tail direction when the bone fixation assembly is attached to the spinal column. The rod body 25 includes, but is not limited to, a solid body, a hollow body, a flexible or dynamic body, etc., and may be in any other form as required. Accordingly, it should be appreciated that the bone fixation assembly 20 is not limited to using any particular spinal fixation rod 24.

  Next, the bone fixation elements 22a to d in the bone fixation assembly 20 will be described with reference to FIG. 1B. In particular, the bone fixation element 22 generally comprises a vertebral implant 75 and a locking cap 34. The vertebral implant 75 includes a bone anchor 30 (as a bone screw) having a bone anchor seat 26, a collet 28 disposed inside the anchor seat 26, and a head portion 33 (see FIG. 3) attached to the collet 28. Are shown). The lock cap 34 is mounted on the anchor seat 26 at a position above the collet 28, and the spinal fixation rod 24 is located in a rod slot 36 disposed between the collet 28 and the lock cap 34. ing.

  Referring also to FIG. 3, the bone anchor 30 is configured as a bone screw or a vertebral screw, and includes a male screw shaft portion 31 that is coupled to an enlarged curved head 33 at the upper end. The shaft 31 extends in the axial direction along the central axis B of rotation and has any suitable diameter, length, and thread design to engage the underlying bone, such as the vertebra 27. Have. As a modification, the shaft portion 31 may be formed as a pin or a claw instead of being threaded if desired. Accordingly, those skilled in the art will recognize that the bone anchor 30 is not limited to any particular type of shaft 31. Also, if necessary, the bone anchor 30 can be cannulated and fenestrated so that the openings extend radially outward from the hollow passage in the center of the cannulated shaft and during injection the bone anchor 30 The fluid may be urged out of the fluid or the fluid may be aspirated from the radial side of the anchor into the central hollow passage during extraction of the material adjacent to the anchor.

  The bone anchor 30 further includes a vertically extending neck 35 coupled between the shank 31 and the head 33. The neck 35 comprises an outer neck surface 37 which is shown as extending in the axial direction in a direction parallel to the axis B and which forms a neck diameter smaller than the diameter of the head 33. Yes.

  The head 33 forms at least partially a spherical curved surface, for example a hemispherical curved surface, or alternatively any desired suitable curved surface, as will be described in detail below. It is easy to rotate with respect to. The head 33 also receives a corresponding tip of a drive tool, such as a screwdriver configured to rotate the bone anchor 30 to engage the surface of the vertebra 27 or other underlying bone. A configured drive surface 39 is provided. The drive surface 39 may be a hexagonal, star-shaped drive pattern, a Phillips head pattern, a slot, or a threaded portion configured to accept a corresponding screw of a threaded drive post, or any desired Any suitable drive tool engagement structure can be formed.

  Referring now to FIG. 4, the anchor seat 26 extends centrally along an axis A that extends generally in the anteroposterior direction when the bone anchoring element is implanted into the underlying vertebra. An anchor seat body 38 disclosed as a generally cylindrical tubular body is provided. The main body 38 includes a base 40 and a pair of opposed arms 42 protruding from the base 40 (upward in the drawing). The arms 42 are configured substantially the same or the same. The arm 42 forms a corresponding upper end 46, which is the upper end of the main body 38, and forms an upper opening 48. The base 40 forms a lower end 50 that is the lower end of the main body 38 and forms a lower opening 52. The main body 38 forms an axial bore 54 that extends from the lower opening 52 to the upper opening 48.

  The main body 38 includes an opposing support wall portion 56 and a pair of opposing spacer wall portions 58 that are coupled between the support wall portions 56 and spaced apart from each other. The support wall portion 56 is configured to be substantially the same or the same, and the spacer wall portion 58 is also configured to be substantially the same or the same. The arms 42 protrude from the respective support wall portions 56 and are formed in a desired shape. As shown in the drawing, the arm 42 has an arc shape and has an arc axis passing through a symmetry plane that bisects the anchor seat portion 26. Each arm 42 extends less than 180 °, for example approximately 90 °, around its axis, such as between 60 ° and 150 °. For example, each arm 42 extends 90.5 ° around the circumference of its axis.

  Therefore, a gap G extends circumferentially between the adjacent outer circumferential ends of the arms 42. Opposing gaps G are aligned with respect to the axial bore 54. The arms 42 are arranged radially opposite one another and the gap G, in combination with the alignment portion of the axial bore 54, forms a rod receiving passage 36, the size and structure of which receives the spinal fixation rod 24. Thus, the spinal fixation rod 24 extends through the bone fixation element 22. Accordingly, the gap G is aligned in the longitudinal direction. Spinal fixation rod 24 therefore extends through opposing gap G and axial bore 54. Arm 42 forms radially inner and outer surfaces 60 and 62, respectively. A screw 62 is formed on the inner surface 60 and is configured to screw the lock cap 34 as described below.

  More specifically, with reference to FIGS. 5A-5C, the lock cap 34 is shown as comprising a set screw 64 and a saddle portion 66 operatively coupled to the set screw 64. The set screw 64 includes a substantially cylindrical set screw main body 65 having a male screw 68 configured to be screwed with a screw portion 62 formed on the inner surface 60 of the arm 42. According to one embodiment, the threads 68 and 62 incorporate inclined load flank formed obliquely with respect to the axis A of the bone anchoring element 22. The load flank is converged so that the upper surface of the threaded portion and the bottom surface of the threaded portion converge. The angle is between 0 ° and 30 °, and in one embodiment about 5 °. Those skilled in the art will recognize that the threaded portion can take the form of any variation as desired, including negative load screws, vertical screws, sawtooth screws, and the like.

  The male set screw 64 generally prevents the spinal fixation rod 24 from fully seating within the body 38 prior to engagement of the locking cap 34 when the spinal fixation rod 24 is inserted into the anchor seat body 38. Provides the flexibility of not having to sit. The set screw 64 is configured to abut against the spinal column fixing rod 24 and be tightened inside the anchor seat portion 26. Lock cap 34 is constructed as desired for such purposes and includes, but is not limited to, male thread caps, right angle or partial rotation lock caps, two piece set screws, and the like.

  The set screw 64 is shown as having a drive surface 70 provided as an inner recess extending vertically downward from the upper end of the screw 64. The drive surface has any suitable shape and is configured to cooperate with a corresponding drive tool for screwing the set screw 64 to the anchor seat body 38. The drive surface 70 can be formed in any desired shape, for example, corresponding to a hexagonal outer surface, a star drive pattern, a Phillips head pattern, a slot, or a threaded drive post for screwdrivers. There are other screws.

  With continued reference to FIGS. 5A-5C, the saddle 66 includes a saddle body 72 having a transverse recess 74 extending upwardly from the bottom end of the saddle body 72. The recess 74 forms a rounded surface extending about a longitudinally extending axis, and the recess 74 is configured to receive the spinal fixation rod 24 at the rod contact surface 76. The rod contact surface 76 has a desired surface finish that adds roughness, for example, knurling, bead blasting, grooves, or other texture finishes to increase surface roughness and increase rod push-through strength. There are things to improve.

  The saddle 66 is coupled to the set screw 64 in any desired manner such as gluing, mechanical fixation, or the like. In the illustrated embodiment, the saddle 66 includes a mandrel 78 extending upward from the center of the saddle body 72. The mandrel 78 is configured to be received in the central bore 32 extending vertically toward the lower end of the set screw body 65 and secured to the interior of the central bore using a rivet 80 or other similar fastener. Is done. Thus, the saddle 66 is rotatable with respect to the set screw 64, such as when the lock cap 34 is tightened against the spinal fixation rod 24 and the set screw 64 is rotated with respect to the anchor seat 26. Sometimes it is self-aligned to the spinal fixation rod 24.

  Referring to FIG. 4 again, as described above, the anchor seat portion main body 38 has a pair of spaced apart support walls 56 and a pair of spaced apart support wall portions 56 coupled to each other. Opposite spacer walls 58. The arms 42 extend upward from the respective support wall portions 56, and the spacer wall portions 58 are arranged between the arms 42. Each spacer wall 58 forms an upper end 84 and a lower end 82 that face each other and have a desired shape. In the illustrated embodiment, the upper end portion 84 is round and is adjacent to the upper end portion 84 and the circumferential outer end portion 42 of the arm 42, and forms a substantially U shape in a horizontal view through the gap G. ing. Accordingly, the upper end portion 84 forms the lower end of the gap G.

  The shape of the upper end 84 is generally coincident with the outer surface of the spinal fixation rod 24, and the upper end 84 receives and engages the spinal fixation rod 24 during use. Alternatively, the upper end 84 is slightly spaced below the upper surface of the collet 28 so that the collet 28 supports the spinal fixation rod 24 during use, as described in detail below. Anyway.

  Each support wall 56 forms opposing inner and outer surfaces 86 and 88, respectively. The support wall 56 and the spacer wall 58 are narrowed inward toward the central axis A downward from the arm 42, and terminate at the respective lower end portions 90. The inner surface 86 facing the support wall 56 and the spacer wall 58 forms a distance D, which is smaller than the distance between the inner surfaces 60 facing the radial direction of the arm 42. The distance D can be either smaller or larger than the diameter of the head 33 of the bone anchor 30. The inner surface 86 is constricted radially inward, downward, toward the central axis A and toward each other, on the bottom and innermost surfaces forming respective abutment walls 92. , Each is coupled.

  Referring to FIGS. 4 and 7A, each abutment wall 92 forms an inner abutment surface 93, and the distance formed between them is substantially equal to the diameter of the neck 35, and The abutment wall 92 is configured to abut against opposing abutment surfaces of the bone anchor, which are opposite sides of the neck outer surface 37 when the bone anchor 30 is positioned within the anchor seat 26. Shown as part. The abutment wall 92 prevents or limits the bone anchor 30 from pivoting relative to the anchor seat 26 in a desired plane.

  Referring now to FIG. 6, the collet 28 includes a collet body 45, which is a first to upper end 47, when the rod is received within the rod receiving passage 36. Having a size and structure that contacts or supports at least a portion of the fixation rod 24, and a second or lower end 49, directly or indirectly, on a portion of the bone anchor head 33. Having a size and structure for making contact or other engagement. The collet body 45 has an annular shape, thereby forming an axial bore 53 extending between the upper end 47 and the lower end 49. The axial bore 53 is aligned with the axial bore 54 when the collet 28 is installed in the anchor seat 26.

  Referring to FIGS. 6, 7A, and 7B, the upper end 47 has a curved or hemispherical shape corresponding to the outer surface of the spinal fixation rod 24, is opposed to the radial direction, and is a seat 51 that faces upward. And thus is configured to receive or otherwise support at least a portion (eg, the lower portion) of the rod 24. The lower end 49 forms an inner surface 55 having a curved or hemispherical shape corresponding to the outer surface of the anchor head 33 and is thus configured to receive or otherwise engage at least a portion of the head 33. The head can be rotated with respect to the collet 28 and the anchor seat 26, and further allowed by the anchor seat 26 to pivot with respect to the collet 28. Since the bone anchor 30 is free to rotate about its axis of rotation B relative to the anchor seat 26, the anchor seat 26 can likewise rotate about the bone anchor 30, so that the rod receiving passage 36 is , Aligned with respect to the spinal fixation rod 24 without advancing or retracting the bone anchor 30 in or out of the underlying bone. Thus, the bone anchor 30 can maintain a constant insertion depth into the underlying bone (eg, vertebra 27) while adjusting the orientation of the rod receiving passage 36.

  The collet 28 further includes a pair of flanges 57 that project upward from the upper end 47 of the collet body 45 at a radial position between the seats 51. From each flange 57, the lock lip part 59 is extended radially. As best shown in FIG. 7A, the anchor seat 26 forms a pair of opposing recesses 61 (see FIG. 8A) that are located below the threaded inner surface 60 of the arm 42, The inner surface 86 of the support wall 56 is formed in the radial direction. During the operation, the collet 28 is inserted into the anchor seat 26 from top to bottom so that the flange 57 bends inward and passes through the threaded inner surface 60 until the lip 59 is recessed. The flange 57 snaps back and the lip 59 is disposed in the recess 61 at the place where the upper end of 61 is passed. Interference between the lip 59 and the upper end of the recess 61 prevents the collet 28 from going out through the upper end of the anchor seat 26. The recess 61 further forms a circumferential length substantially equal to the flange 57 and the lock lip 59, and the collet 28 is fixed in position with respect to the anchor seat 26 for rotation, so that the spine When the fixation rod 24 is inserted into the anchor seat 26, the upper surface 47 is aligned with the spinal fixation rod 24.

  The lower end portion 49 of the collet 28 has a larger outer diameter than the inner distance between the contact wall portions 92. Accordingly, the collet 28 cannot pass through the lower end portion of the anchor body 26 downward in the axial direction. The lower end 49 comprises one or more slots 67 (illustrated as a plurality of slots) that extend radially through the lower end so as to pop over the head 33 of the bone anchor 30. A plurality of opposing finger portions 69 configured as described above are formed. When the collet 28 is disposed in the anchor seat portion 26 and the lips 59 are disposed in the respective recesses 61, the finger portions 69 are aligned in the axial direction with respect to the contact wall portion 92. Thus, as shown in FIGS. 7A and 7B, when the collet 28 and the anchor 30 are installed in the anchor seat 24, the fingers 69 expand radially and the outer surface of the anchor head 33 and the anchor seat It coincides with the inner surface of the portion 26. The inner diameter formed by the opposing fingers 69 is smaller than the outer diameter of the anchor head 33, and the anchor 30 is prevented from detaching downward from the anchor seat 26 in the axial direction. The lower end portion of the finger portion 69 terminates at a position above the contact wall portion 92. Therefore, the finger portion 69 does not interfere with the engagement between the anchor neck portion 35 and the contact wall portion 92.

  8A-8D, the method of assembling the vertebral implant 75 comprises, as step 1, the step of inserting the bone anchor 30 through the axial bore 54 vertically downwardly, The anchor head 33 is disposed above the contact wall 92 through the lower opening 52 at the lower end 50 of the anchor seat 26. In this method, the step of inserting the bone anchor 30 into the anchor seat 26 can be referred to as the top loading of the bone anchor 30 onto the anchor seat 26. Next, in stage 2, the collet 28 is inserted into the axial bore 54 and placed in place so that the lock lip 59 engages the lower threaded portion 62 on the inner surface 60 of the arm 42. Will be able to match. Next, in stage 3, an upward force is applied to the bone anchor 30 to insert the anchor head 33 into the lower end 49 of the collet 28. The lock lip portion 59 of the collet 28 is received in contact with the anchor seat portion 26 inside the screw portion 62, and the upward force applied by the screw 28 causes the collet 28 to move from the upper opening of the anchor seat portion 26. To prevent it from coming out. In stage 4, a downward force is applied to the collet 28, thereby inserting the locking lip 59 into the recess 61 and engaging the anchor 30 and collet 28 into the anchor seat 26 in the manner described above. Stop.

  In use, the bone anchor 30 is rotatable relative to the collet 28 and the anchor seat 26 so that the drive tool is engaged with the drive surface 39 of the head 33 and, as shown in FIG. Attached shaft 31 can be inserted into the underlying bone. Next, as shown in FIGS. 8A to 8D, the anchor seat 26 can be rotated in the direction of the arrow R about the axis A at an angle in the range of 360 °, and the rod receiving passage 36 is fixed to the spine. It can be aligned with the longitudinal axis of the rod 24. Accordingly, the vertebral implant 75 can be referred to as a polyaxial vertebral implant, and the bone fixation element 22 can be referred to as a multiaxial bone fixation element. As a variant, it should be recognized that the bone anchoring element may allow the anchor seat 26 to rotate in one plane relative to the axis A and is therefore referred to as a uniaxial vertebral implant. Further, it should be appreciated that the vertebral implant may include a hook as a bone anchor 30 instead of a screw. Once the bone anchor 30 has reached the desired depth in the underlying vertebra, the spinal fixation rod 24 can be inserted into the vertebral implant 75. More particularly, spinal fixation rod 24 is inserted into axial bore 54 either horizontally through gap G or vertically downward. It will be appreciated that the spinal fixation rod sits on the upper end 47 of the collet 28.

  With continued reference to FIGS. 8A-8D, once the rod 24 is installed in the vertebral implant 75, the lock cap 34 is attached to the assembly 75 and the anchor assembly 22 is fully assembled. In the illustrated embodiment, the male screw 68 of the set screw 64 rotates within the female screw 62 of the anchor seat arm 42, thereby moving the set screw and saddle 66 axially downward within the axial bore 54. . As the saddle 66 approaches the spinal fixation rod 24, the saddle 66 rotates relative to the set screw 64 to align the rod contact surface 76 with the spinal fixation rod 24. Once the saddle 66 is aligned with the spinal fixation rod 24, the set screw 64 continues to be screwed into the bone anchor 26 and the lock cap 34 is tightened against the rod 24, thereby lowering the rod 24. Gives axial force in the direction. Although the lock cap 34 is installed on the lock cap 34, it can be said that the lock cap 34 is in the initial position before the axial force is applied to the spinal fixation rod 24. The axial force applied to the rod 24 by the lock cap 34 is transmitted to the collet 28, whereby the finger portion 69 rides along the inner surface 86 of the support wall portion 56 and the spacer wall portion 58.

  When the finger 69 rides along the walls 56 and 58, the finger is displaced radially inward due to the inward stenosis of the inner surfaces of the walls 56 and 58, thereby The finger 69 is urged in the radial direction with respect to the anchor head 33 or compressed in the radial direction. Increased radial compression of the finger 69 against the anchor head 33 causes a frictional force between the finger 69 and the anchor head 33, and thus the anchor seat 26, collet 28, and spinal fixation rod 24. The rotation of the anchor 30 about the axis A with respect to is subject to resistance. When the lock cap is fully tightened to the locked position, the resulting frictional force prevents the anchor 30 from moving relative to the anchor seat 26, the collet 28, and the spinal fixation rod 24. The Accordingly, the lock cap 34 is configured to transmit a locking force to the collet 28 and the bone anchor 30, and fixes or locks the position of the bone anchor 30 with respect to the anchor seat 26 and the spinal column fixing rod 24. Thus, it will be appreciated that the spinal fixation rod 24 is implanted into the underlying vertebra with which the bone anchor 30 is engaged.

  It should be appreciated that the method steps described above are performed for each bone fixation element of the bone fixation assembly 20 as needed. Further, although the bone fixation elements 22a-d are each said to comprise the vertebral implant 75 described above, the bone fixation elements 22a-d are suitable for fixing the spinal fixation rod 24 to the underlying vertebra 27. It should be appreciated that vertebral implants constructed according to any variation may be included. For example, the vertebral implant 75 can also be constructed to allow the bone anchor 30 to be implanted into the underlying bone before the anchor head 33 is inserted into the collet 28. In one embodiment, the abutment wall portion 92 is provided with a slot so that it extends over the anchor head 33. Thereby, the anchor seat 26 and the collet 28 can be mounted on the head 33 from above instead of inserting the anchor 30 down through the anchor seat 26 in the manner described above. The step of mounting the anchor seat portion 26 on the head portion 33 can be referred to as bottom loading of the anchor 30 on the anchor seat portion 26. Further, although the bone fixation assembly 20 including the bone fixation element 22 and the vertebral implant 75 has been described in connection with one embodiment, the bone fixation assembly 20 including the bone fixation element 22 and the vertebral implant 75 may include a plurality of It should be appreciated that the device can be constructed according to any embodiment suitable for being implanted into a vertebra and joined by a spinal fixation rod, and means for doing so are described, for example, in US Pat. No. 11 / 603,428, which is disclosed in a document published on May 24, 2007 as US Published Patent Publication No. 2007/0118123, the contents of which are hereby fully incorporated by reference. To do.

  Referring now to FIG. 9, although the spinal fixation rod 24 has been implanted in the plurality of vertebrae 27a-d by the bone fixation assembly 20, at a future date, the bone fixation assembly 20 is extended to at least 1 It should be appreciated that it may be necessary to fix one, eg, multiple, vertebrae to vertebrae 27a-d. For example, it may be desirable to secure at least one, eg, a plurality, lower vertebrae 27e-f to vertebrae 27a-d. Alternatively or additionally, it may be desirable to fix at least one, eg, a plurality, upper vertebrae 27g-h to vertebrae 27a-d. Thus, the spinal fixation rod 24 can be referred to herein as an already implanted spinal fixation rod. As shown in the drawing, the vertebra 27 a is the most cranial vertebra fixed to the spinal column fixing rod 24, and the vertebra 27 d is the most caudal vertebra fixed to the spinal column fixing rod 24. The vertebra 27g is above the vertebra 27a, and the vertebra 27h is above the vertebra 27g. The vertebra 27e is below the vertebra 27d, and the vertebra 27f is below the vertebra 27e. The vertebrae 27g-h and 27e-f are referred to as new vertebrae.

  Referring now to FIGS. 10A-10D, the extension system 100 includes a top-loaded, multi-axial spinal construction extension 105, which may be an already implanted bone fixation element 22 or newly implanted. One or more vertebrae that are configured to operatively connect to the spinal fixation rod 24 of the bone fixation element that has been previously connected to each other using the bone fixation system 20 to adjacent bone. To be connected. Accordingly, the polyaxial spinal build extension 105 is configured to expand the bone fixation system 20 to one or more adjacent spinal levels. As those skilled in the art will appreciate, the multiaxial spinal column construction extender 105 is not limited to expanding an already implanted structure, but can be used for initial spinal surgery to minimize potential invasiveness. In a sexual manner, multiple levels of patient vertebrae can be fixed.

  The multiaxial build extension 105 includes a multiaxial extension member 139 that is substantially cylindrical, forming a proximal end 141a and an opposite distal end 141b. It is constructed as a rod 140 having a rod body 141. The multiaxial extension rod 140 includes an engagement member, illustrated as a loop 142 attached to the proximal rod body end 141a, and an opening 143 extending vertically through the loop 142. Yes. The distal end 141b may be coplanar with the loop 142 as shown. As a variant, the distal end 141b may be diagonal or otherwise vertically offset with respect to the loop 142. The multiaxial extension rod 140 further includes a bushing 150 disposed within the opening 143 and secured to the loop 142. The extension 105 is further configured as a tapered set screw 130 that is configured to couple to both the bushing 150 and the anchor seat 26 (of the already implanted bone fixation system 20 or a new bone fixation system). It includes the illustrated locking fixture and a locking member illustrated as a lock nut 160 configured to lock the extension rod 140 to the set screw 130.

  Tapered set screw 130 includes a proximal portion 130a, a distal portion 130b, and an intermediate portion 130c disposed between the proximal portion 130a and the distal portion 130b. The set screw 130 has a non-tapered outer surface on the proximal portion 130 a that has a male thread 131 that is configured to engage the female thread of the lock nut 160. Yes. The distal portion 130 b of the tapered set screw 130 includes an untapered outer surface 132 that has a male thread 133 that engages the female thread of the anchor seat 26. It is configured. The set screw 130 includes an outer surface 134 that is tapered and unthreaded at the intermediate portion 130 c and is configured to abut the inner surface 151 of the bushing 150. The tapered outer surface 134 is configured such that the circumference of the intermediate portion 130c increases along the direction from the proximal portion 130a to the distal portion 130b.

  The bushing 150 includes a flat upper surface 152, a flat lower surface 153, a central longitudinal axis 154 extending between the upper surface 152 and the lower surface 153, and between the flat upper surface 152 and the lower surface 153. A partially spherical outer surface 155 extending to the inner surface 151 and an inner surface 151 surrounding the hollow interior 156. The bushing 150 includes a split 157 extending along the longitudinal axis through the outer surface 155 and the inner surface 151 so that the circumference of the bushing can be expanded when the tapered set screw 130 is pushed into the interior 156. It has become.

  The inner surface 151 of the bushing 150 includes a lower taper portion 151a and an upper taper portion 151b. The lower taper portion 151a extends between the lower surface 153 and the intermediate point of the inner surface 151, while the upper taper portion. 151 b extends between the upper surface 152 and the midpoint of the inner surface 151. The intermediate point of the inner surface 151 is a substantially circular line that forms the apex 158 by the intersection of the two tapered portions. Each of the lower tapered portion 151 a and the upper tapered portion 151 b preferably forms an angle with respect to the longitudinal axis 154, and this angle matches the taper angle of the outer surface 134 of the intermediate portion 130 c of the tapered set screw 130. I'm doing it.

  The bushing 150 is press-fitted into the opening 143 of the loop 142 of the extension rod 140. The partially spherical outer surface of the bushing 150 is generally similar or identical to the spherical geometry of the inner surface of the loop 142, and the bushing 150 is in the initial state prior to insertion of the screw 130 in the opening 143. Multi-axis rotation is possible inside. Once the screw 130 is inserted into the bushing 150, the tapered outer surface 134 of the screw 130 rides along the bushing inner surface 151, expanding the crack 157, and the bushing outer surface 155 is pressed against the inner surface of the loop 142. Thus, the position of the bushing 150 within the loop 142 is locked.

  Referring now again to FIG. 9, the system 100 comprises a newly implanted bone fixation element 22g that is placed in an adjacent vertebra, such as the illustrated upper vertebra 27g or lower vertebra 27e, for example. Yes. The multiaxial extension rod 140 provides a spinal fixation rod that extends through the anchor seat 26 of the newly implanted bone fixation element 22g. Thus, the multiaxial extension rod 140 is comprised of a newly implanted bone anchoring element 22g and a separate bone anchoring element 22a, for example, a portion of an already implanted bone anchoring assembly 20. Coupled between.

  Thus, during surgery, the top-loaded multi-axially constructed extension device 105 may include a bone fixation assembly 20 that includes an already implanted spinal structure or an already implanted bone fixation element 22a. Extends to adjacent bones, shown as adjacent spinal levels, providing a firm bond between the two during corrective surgery. The incision is made to the extent necessary for correction, for example, at the vertebral level, adjacent to the level of the existing spinal structure, most cranial (or most caudal). The incision is made over the extreme end of the existing bone fixation element 20 and the new vertebra to be attached, and it is not necessary to cut over the other vertebrae 27a-27d in the existing bone fixation element 20. This is because the existing spinal fixation rod 24 is not removed. First, a new bone anchoring element 22g is implanted into the adjacent spinal level 27g, with the exception of the lock cap 34. In other words, the vertebral implant 75 of the new bone anchoring element 22g is implanted in the adjacent spinal level 27g. Through the same incision or using a second incision, the locking cap 34 is removed from the extreme end, eg, the most cranial bone anchoring element 22a (or the most caudal bone anchoring element 22d).

  Next, the screw 133 at the distal end 130b of the tapered set screw 130 is screwed inside the anchor seat 26 to couple the tapered set screw 130 to the bone fixation element 22a that has already been implanted. . Since the locking cap 34 of the already implanted vertebral implant 22a has been removed, the tapered set screw 130 can be coupled to the polyaxial vertebral implant 75 of the bone fixation element 22a that has already been implanted. Next, the bushing 150 held within the loop 142 to couple the extension rod 140 between the previously implanted polyaxial vertebral implant 22a and the newly implanted vertebral implant 22g. Is placed around the middle portion of the tapered set screw 130 and the other end of the extension rod 140 is inserted vertically downward into the anchor seat 26 of the newly implanted bone anchoring element 22g. Due to the spherical surface 155 of the bushing 150 and the complementary spherical inner surface 147 in the loop 142 forming the opening 143, the bushing 150 can rotate in a multiaxial manner inside the opening 143 of the loop 142. Permissible. The double-tapered inner surface 151 of the bushing 150 provides a degree of freedom in the orientation of coupling the extension rod 140 to the tapered set screw 130 because of the opposing orientation of the taper. This is because the extension rod 140 can be coupled to the tapered set screw 130 from any direction, and there is no wrong orientation.

  The lock nut 160 is then placed over the proximal or upper portion 130a of the tapered set screw 130 by engaging, for example, an instrument engagement feature provided on the outer or upper surface of the lock nut 160. Screwed, the extension rod 140 and bushing 150 are advanced by pushing them distally against the intermediate portion 130b of the tapered set screw 130, while the bushing 150 is spread out to taper the inner surface 151 and taper. The outer surface 134 of the intermediate part 130c of the attachment set screw 130 is matched and locked by an interference fit. The locking cap 34 is then placed on top of the anchor seat 26 until the angular orientation of the bone anchor 30 is locked relative to the anchor seat 26 and the extension rod 140 is secured to the bone anchoring element 22. Screw in. As shown in FIG. 10D, the extension rod body 141 is substantially “S-shaped” and the proximal end 141a is disposed rearward relative to the distal end 141b. Alternatively, the extension rod 140 may be substantially straight, or have a substantially constant or variable curvature (see FIGS. 14A-14C), and the proximal end 141a may be The bushing 150 is oriented so that it is located rearward relative to the distal end 141b. Thus, the proximal end 141 a can be mounted over the existing spinal fixation rod 24, while the distal end 141 b can be substantially aligned with the existing spinal fixation rod 24. If the system 100 comprises parallel rows 101a and 101b of the fixation element 22 and spine construction extension 105, the above-described mounting procedure is repeated for the opposite rows.

  In order to extend the previously implanted bone fixation assembly 20 to the caudal rather than the cranium, the top-loaded polyaxial spinal construction extension 105 is replaced with the lower bone fixation in the manner described above. Coupled to the vertebral implant 75 of element 22d, the new bone anchoring element is anchored to a lower vertebra such as vertebra 27e, and the extension rod 140 is the vertebral implant of the lowest existing anchoring element 22 in the manner described above. 75 and a newly implanted bone anchoring element.

  The top-loading possibility of system 100 allows for less invasive, less difficult and less time consuming corrective surgery, which is a traditional spinal revision surgery system. And the method generally uses another large incision with significant blood spillage to disassemble the entire already-implanted spinal structure and fuse it to the adjacent spinal level, This is in contrast to the need to reassemble with a longer rod. The system 100 generally reduces the required incision length as well as the surgical time, blood outflow, post-surgical pain, and time to healing. Furthermore, the system 100 according to the first preferred embodiment allows the use of minimally invasive techniques when constructing multiple levels of spinal rod assemblies, because of the relatively short length extension The rod 140 allows multiple fixation screws and extension rods 140 to be inserted into a single small incision, followed by stacking the rods across multiple levels, and the extension rod 140 to engage the fixation screws with relatively easy manipulation. It is.

  It will be appreciated that the rod 140 can also include a dampening mechanism, for example, to provide additional movement as needed between one portion of the rod 140 and the loop 142. In addition, the rod 140 is made entirely of an elastic material and provides a more dynamic connection between levels. For example, the rod body 141 and / or the loop 142 are constructed from polyetheretherketone (PEEK) material to allow buffering or limited movement between adjacent polyaxial vertebral implants 75. The loop 142, rod 140, bushing 150, lock nut 160, set screw 130, spinal rod 42, anchor seat 26, and / or other elements of the system 100 prevent over-extension and excessive compression of elements relative to each other. For this reason, even if certain components allow movement or are dynamically constructed, they are configured to limit the ultimate movement of the elements relative to each other.

  Referring to FIGS. 11A-11C, as described above, the system 100 has been described as extending an existing structure to one adjacent spinal level, such as the upper vertebra 27g or the lower vertebra 17e, for example. The 100 may further comprise two or more top-loaded multiaxial cascade construction extensions 105 and a corresponding number of new bone anchoring elements 22, the system not previously secured. It can also be used to attach to multiple vertebrae. For example, the polyaxially constructed extension device 105 is attached to the newly implanted bone fixation element 22g in the manner described above, and the newly implanted bone fixation element 22 is attached to the vertebrae in the manner described above. It can be attached to the adjacent upper vertebral body 27h above the body 27g. Thereby, the extension rod 140 couples between the multiaxially constructed extension device 105 attached to the bone anchoring element 22g and the newly implanted bone anchoring element 22 implanted in the vertebral body 27h. . Accordingly, it should be appreciated that the cascaded extension 105 can be attached to the newly implanted vertebral bodies 27g and 27h, rather than attached to an already implanted fixation system.

  Transplantation of cascaded extension devices can be done with minimal invasiveness because a single incision formed rather than making incisions along all vertebral levels to be attached This is because the cannula can be accommodated at a single vertebral level. Implantation can be performed at each vertebral level through a cannula tube or retractor extending through the incision, and implantation of the extension device 105 constructed in a cascade fashion by pivoting the tube or pivoting or expanding the retractor. Provides access to adjacent vertebral levels to be done.

  As shown in FIG. 11A, the cascading extension system 100 may comprise a top-loading, multiaxially constructed extension 105 alone or a plurality of already implanted corresponding bones. It should be appreciated that the fixing element 22 may be combined. A plurality of individual extension rods 140 can be replaced with a multiaxial bushing 150 held in the spinal fixation rod 24 and loop 142 as needed to provide the desired angular adjustment capability and Allow an overload connection to the anchor seat 26 of the bone anchoring element 22 to be implanted.

  Conventional cervical spine surgery techniques typically utilize a hook, and generally a first shallow trajectory for securing the hook to the bone and a first for coupling the hook to the spinal rod 120. Required two vertical trajectories. Two separate tracks required a large incision to access the surgical site. The surgical method using the system 100 shown in FIG. 11A generally involves implanting each newly implanted bone anchoring element 22 and a top-loaded multiaxially constructed extension device 105 to provide an extension rod. Only one trajectory is required to introduce 140 and finally tighten lock nut 160. Therefore, according to the system 100 according to the third preferred embodiment, instead of a large incision, a percutaneous stab or one small incision can be utilized. The trajectory used during implantation of the system 100 is similar to the widely used Magrel-type technique and trajectory.

  As shown in FIGS. 11C and 11D, the system 100 further includes one or both transverse connectors 190 and 193 configured to connect the rows 101a and 101b. The transverse connector 190 includes a transverse connector rod 191 and clamps 192 coupled to opposite ends of the rod 191, which are configured to receive and secure spinal fixation rods 24 in rows 101a and 101b, respectively. Has been. The transverse connector 193 includes a transverse connector rod 194 that forms a pair of rod portions 194a and 194b that can be coupled together using any suitable mechanical joint 195. The transverse connector rod 194 includes a first loop 196a disposed at the outer end of the first rod portion 194a and a second loop 196b disposed at the outer end of the second rod portion 194b opposite thereto. It has. Each loop 196a-b can be constructed as described above with respect to loop 142 of extension rod 140. Accordingly, the system 100 includes a spinal construction extension 105 ′ that has been modified with respect to the spinal construction extension 105, that is, a transverse connector 193 is provided in place of the extension rod 140. The modified spinal build extension 105 'is attached to the outermost bone fixation element 22 as described above, and the transverse connector rod 194 is coupled between the outermost vertebral implants 75 in rows 101a and 101b. Is done.

  Referring now to FIG. 12, it should be appreciated that the top-loaded multiaxially constructed extension 105 can be constructed in accordance with an alternative embodiment. More particularly, although the extension 105 can be constructed as described above, the extension member 139 is constructed as a plate 180 and is opposite the proximal end 181a and the proximal end 181a along the longitudinal central axis 185. A plate body 181 formed with a distal end 181b, the plate body further having an intermediate portion 181c disposed between the proximal end 181a and the distal end 181b. Yes. The distal end 181b is pivotable with respect to the intermediate portion 181c as shown by arrow 187 and is matched to the underlying bone anatomy to be attached. Plate body 180 includes an engagement member shown as a loop 182 coupled to proximal end 181a. The loop 182 is constructed as described above with respect to the loop 142 of the rod 140 and the bushing 150 is retained within the loop 182 in the manner described above.

The plate 180 has a plurality of openings 183 drilled in the intermediate portion 181c and the distal end 181b, which are spaced apart in the longitudinal direction along the length of the plate body 181. The openings 183 are each configured to receive a bone anchor such as the bone anchor 30 described above, the bone anchor being a compression screw or a lock screw that allows the plate body 181 to move the underlying bone, eg, Fix directly to vertebral body 27 or lamina, etc. Opening 183 is at least one circular opening 184 sized to receive a bone anchor in a fixed position and at least one longitudinally elongated opening or slot 186 sized to receive the bone anchor. And aligning the bone anchor with the underlying bone prior to tightening the bone anchor against the plate body 181. help. Alternatively, the slot 186 has been inserted into the plate body 181 in laminoplasty, may hold the bone graft material. In the illustrated embodiment, the extension plate 180 is malleable so that the geometry of the plate body can be adjusted before or during surgery. One or more or all of the openings 183 may be unthreaded and the anchor 30 may press the plate against the underlying bone, but one or more or all of the openings 183 may be threaded. Alternatively, the bone anchor 30 may include complementary screws that match the threaded portion of the opening 183 so that the plate 180 does not press against the underlying bone without pressing the bone anchor against the underlying bone. Can be fixed or locked.

During surgery, the extension device 105 is coupled in the manner described above to a polyaxial bone anchoring element 22 that has already been implanted, or is newly implanted or newly implantable. . The second end of the extension plate 180 is secured directly to a bone, such as a vertebral lamina. Formed by including an extension plate 180, the top loading type polyaxial plate extension device 105 generally constructed to include a graft, especially, under direct vision laminoplasty (bone underlying allografts And / or in longer cranio-caudal fusion constructs. For example, the plate 180 is placed over the vertebral body 27 to be fixed, and the bone anchor 30 of the bone anchoring element 22 is inserted through the complementary opening 183 so that the underlying vertebra 27 is Both the fixing element 22 and the plate 180 can be fixed. Thus, the plate offers the possibility of combining laminoplasty with posterior fusion using a single structure. Conventional plastic surgery typically utilizes cables to house such grafts, but the extension plate 180 generally provides a more robust graft containment method, and The possibility of a top-loaded multiaxial connection provided by the extension 105 is a rigid fixation point when anatomy is not available or is inappropriate to function as an attachment point. Can be provided. Furthermore, the top-loading attachment points are typically quicker and easier to assemble than today's wire technology.

  Referring now to FIGS. 10A-10D and 13, the extension 105 includes an extension member 139, which is in the form of a rod 206 along the proximal end 206a and the central axis 210 of the rod. A distal end 206b opposite the proximal end and an intermediate portion 206c disposed between the proximal end 206a and the distal end 206b. The rod 206 includes an extension member, which is shown as a loop 207 that is coupled to the proximal end 206a. The rod 206 further comprises a bushing 150 which is held in the loop 207 in the manner described above with respect to the loop 142. The intermediate portion 206c and the distal end 206b can be offset obliquely with respect to the loop 207, if desired. In this regard, the kit of rods 206 can include ones formed with different angles between the intermediate portion 206c and / or the distal end 206b and the loop 207.

During surgery, the extension device 105 couples an already implanted or newly implantable bone anchoring element 22 to an already implanted lamina penetrating screw. More particularly, the locking cap 34 is removed and the tapered set screw 130 is coupled to the already implanted bone fixation element 22 in the manner described above. Then, the rod 206, to couple between the bone anchoring element 22 and the lamina through screw, the bushing 150 is disposed around the intermediate portion 130c of the tapered locking screw 130, the distal end 206b vertebral arch Place it in the rod seat of the plate penetration screw. The lamina penetrating screw is constructed as described above for vertebral implant 75 and is used to secure adjacent vertebrae and fuse them together as is known to those skilled in the art. More particularly, the lamina penetrating screw is inserted through the facets of the adjacent vertebrae and the lamina to secure the adjacent vertebrae together.

Next, the lock nut 160 is screwed over the upper or proximal portion 130 a of the tapered set screw 130, thereby pressing the extension rod 206 and the bushing 150, and the intermediate portion 130 c of the tapered set screw 130. The bushing 150 is expanded in a distal direction relative to the bushing 150 to match the taper on the inside of the bushing 150 and the taper on the outside of the intermediate portion of the tapered set screw 130, as described above. These are locked by an interference fit. Next, locking cap 34 of the lamina through screw is screwed into the top of the anchor seat lamina through screw, finally, the angular orientation of the bone anchor 30 of the lamina through screw, vertebral arch Locked against the plate seat screw anchor seat 26, the extension rod 206 is locked to the lamina through screw assembly.

Extender 105 is coupled to a lamina penetrating screw at a first end (including multiaxial loop 207 and bushing 150) and rotates about rod axis 210 along the direction of arrow 211. And can be rotated about the central axis B of the screw along the direction of arrow 213, thereby providing an additional degree of freedom for plates that do not provide multiaxial rotation. I want to be recognized.

  9-10D and 14A and 14B, the fixation system 100 is configured to secure the bone fixation element 22 of the bone fixation assembly 20 implanted in the cervical region of the spinal column to the occipital region 253. The occipital plate 250 is configured to be coupled. The occipital plate 250 can take a variety of forms known to those skilled in the art and includes a central body 257 that is configured to receive the distal end 141b of the extension rod 140. It has. For example, the engagement member 252 is an opening that extends longitudinally through the central body 257 and is sized to receive the distal end 141 b of the extension rod 140 so that it is locked relative to the extension rod 140. And a set screw. A pair of occipital plates 250 are illustrated as being clamped to the distal end 141b of each extension rod 140 and have plate portions 250a and 250b, respectively, that project outwardly from the engagement member 252 and are connected to each other. Opposite. Each plate portion 250 a and 250 b can be rotated independently about the rod 140 or can be rotated synchronously about the rod 140. In addition or alternatively, each plate portion 250a and 250b may be bendable about the central body 257. Each plate portion 250a and 250b has at least one bone anchoring opening 255 drilled into it, the size of which is adapted to receive a bone anchor 30, eg, a screw or hook, Parts 250a and 250b are secured to the underlying bone, such as the occipital region.

  During surgery, the fixation assembly 20 is pre-implanted into the cervical region of the spinal column and the bone fixation element 22 is implanted into each underlying cervical vertebra. The extension 105 is attached to the most cranial bone anchoring element 22, which can be newly implanted or implantable after the locking cap 34 has been removed in the manner described above, or Already implanted in the cervical vertebra C (eg, the vertebral implant 75 of the bone fixation element 22 that is most cranial). The second, rod-shaped distal end 141b of the extension rod 140 is coupled to the occipital plate 250 using any of a variety of attachment mechanisms known to those skilled in the art. In the illustrated embodiment, the system 100 comprises first and second columns 101a and 101b of a fixation element 22 and a spine construction extension 105, with the most cranial fixation element illustrated as the occipital region. , Bond to adjacent bone.

  With the top-loaded multiaxially constructed extension 105, the surgeon has a hinged ability when joining the occipital region to the cervical spine, making the operation easier and more flexible. The extension rod 140 can be pre-bent at a desired angle with respect to the loop 142, and its length is short compared to conventional hinge rods that have been used for such applications. Therefore, the top-loaded multiaxially constructed extension 105 is easier to handle and to connect between the cervical spine and the occipital region. Furthermore, with the top-loading, multiaxially constructed extension 105, the surgeon determines whether it is desirable to add hardware for occipital fusion after performing cervical spinoplasty. This is in contrast to traditional hinge rods that had to determine instrument use and hardware at the start of surgery.

  It should be appreciated that multiple correction connector embodiments have been disclosed herein. Thus, a spinal fixation correction connector kit can be provided, which includes a plurality of correction connectors, each correction connector connecting at least one vertebral body to an adjacent bone, eg, an adjacent vertebral body, or occipital region. Configured to combine. Of the plurality of correction connectors in the correction connector kit, at least one correction connector is formed different from at least one anchor of the plurality of correction connectors in the kit. For example, different correction connectors may have different lengths or differently configured polyaxial inner extension members 139. Alternatively or in addition, the different correction connector screws 130 are straight rather than tapered, and the set screws 130 do not lock the bushings 150 within their respective loops so that the bushings are not attached after installation. The joints may be used in each loop. In other words, the loop 142 allows the polyaxial extension member 139 to pivot or articulate in a locked position relative to the screw 130 and the screwed vertebral implant 75. Alternatively or in addition, the distal portion 130b of the screw 130 is provided with a bore hole or a complete through hole, which has already been implanted or newly provided with a female screw disposed distally. The vertebral implant 75 to be implanted is configured to threadably engage with an external thread provided on the outer surface of the anchor seat 26, thereby allowing various vertebral implants or hooks to be used with the internal thread or locking cap. You may adapt to what has a male screw.

  Those skilled in the art will recognize that various modifications can be made to the above-described embodiments without departing from the broad inventive concept. Thus, the present invention is not intended to be limited to the particular embodiments disclosed, but is intended to encompass modifications within the spirit and scope of the present invention as defined by the present disclosure.

Claims (23)

  1. An extension system configured to be operatively coupled to a vertebral implant coupled to a vertebra, the implant including a first bone anchor and a first anchor seat for receiving the first bone anchor And this extension system
    An extension member comprising a body and an engagement member coupled to the body, the extension member forming an opening extending through the engagement member; and
    A bushing disposed in the opening;
    A fixation device configured to couple an engagement member to a vertebral implant, the fixation device capturing a spinal fixation rod disposed within the first anchor seat, thereby providing a first anchor seat. Said fixation device forming a distal portion configured to be attached to a first anchor seat so as to fix the position of the first bone anchor relative to the part and the spinal fixation rod ;
    A second bone anchor, wherein the second bone anchor is attached to an underlying bone disposed adjacent to the vertebra,
    The extension member is pivotable in multiple axes with respect to the bushing.
    An extension system characterized by that.
  2.   The extension system of claim 1, wherein the fixture engages the bushing.
  3.   The extension system according to claim 1, wherein the extension system further comprises a locking member engaging the fixture, wherein the bushing is captured between the locking member and the vertebral implant.
  4.   The extension system of claim 1, wherein the body of the extension member is substantially coplanar with the engagement member.
  5.   The extension system according to claim 1, wherein the body of the extension member is offset relative to the engagement member.
  6.   6. The extension system of claim 5, wherein the body of the extension member is offset perpendicular to the engagement member.
  7.   6. The extension system according to claim 5, wherein the main body of the extension member is offset obliquely with respect to the engagement member.
  8.   6. The extension system according to claim 5, wherein the main body of the extension member is bent.
  9.   9. The extension system according to claim 8, wherein the main body of the extension member is S-shaped.
  10.   The extension system according to claim 1, wherein the extension member comprises a rod comprising a rod body that is substantially cylindrical.
  11.   An extension system further comprising a vertebral implant, the vertebral implant comprising a second bone anchor and a second anchor seat coupled to the bone anchor and configured to receive the extension member; The extension system according to claim 1, further comprising a lock cap configured to secure the extension member within the anchor seat.
  12.   The extension system further comprises a locking member, and the fastener is proximate to a proximal end configured to be attached to the locking member and a distal end configured to be coupled to the first anchor seat. An intermediate portion disposed between the distal end and the distal end, wherein the intermediate portion is received within the bushing and configured to be captured between the lock nut and the anchor seat. The extension system according to claim 1, wherein:
  13.   The extension member forms an opening extending through the engagement member, and at least one of the intermediate portion of the fixture and the inner surface of the bushing is tapered, and the fixture is formed in the opening of the engagement member. 13. The extension system of claim 12, wherein the bushing expands relative to the engagement member when inserted through the intermediate portion of the fixture.
  14.   The extension member includes a plate having a plate body and a plurality of openings extending through the plate body, each opening configured to receive a second bone anchor, the plate body The extension system of claim 1, wherein the extension system is attached to the underlying bone.
  15.   15. The extension system of claim 14, wherein the underlying bone is composed of an allograft.
  16.   2. The extension system of claim 1, wherein the underlying bone is a vertebra.
  17.   2. The extension system of claim 1, wherein the underlying bone is the occipital region.
  18. The extension system of claim 1, wherein the underlying bone comprises a lamina .
  19. The extension system according to claim 1, wherein the extension member is configured to couple the first anchor seat to an already implanted lamina penetrating screw.
  20.   The extension system is further configured to be secured to the occipital region and further includes a occipital plate configured to engage the extension member, the extension member being coupled between the vertebra and the occipital region. The extension system according to claim 1.
  21. A cascade extension system configured to be secured to a plurality of underlying bones, wherein the cascade extension system is
    Provided with a plurality of structural extensions, each structural extension,
    The first bone anchor configured to be implanted in the bone underlying the first, the first bone anchor seat portion configured to receive a first bone anchor,
    An extension comprising a body forming a proximal end and a distal end opposite to and lower than the proximal end, and an engagement member coupled to the proximal end Members,
    A fixture configured to couple an engagement member to a first bone anchor seat, the fixture captures a spinal fixation rod disposed within the first bone anchor seat, and To form a distal portion configured to be attached to the first bone anchor seat so as to fix the position of the first bone anchor relative to the first bone anchor seat and the spinal fixation rod. And the above fixture ,
    A second bone anchor configured to attach the distal end of the extension member to the second underlying bone;
    A cascading extension system comprising:
  22.   The extension member defines an opening extending through the engagement member and further includes a multi-axis pivotable bushing within the opening, and the fixture is configured to couple the bushing to the bone anchor seat. 22. A cascade extension system according to claim 21 wherein:
  23.   The bushing forms an upper surface, a lower surface, and an inner surface extending from the upper surface to the lower surface, and the inner surface has a lower taper portion and an upper taper portion, and the lower taper portion is an intermediate point between the lower surface and the inner surface. The extension system according to claim 1, further comprising an upper taper portion extending between the upper surface and an intermediate point of the inner surface.
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US18790209P true 2009-06-17 2009-06-17
US61/187,902 2009-06-17
PCT/US2010/039037 WO2010148231A1 (en) 2009-06-17 2010-06-17 Revision connector for spinal constructs

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EP2442738B1 (en) 2014-04-30
JP2012530550A (en) 2012-12-06
BRPI1012921A2 (en) 2016-04-05
CN102458279B (en) 2014-10-15
EP2442738A1 (en) 2012-04-25
WO2010148231A1 (en) 2010-12-23
KR20120039622A (en) 2012-04-25
US20170112540A1 (en) 2017-04-27
CN102458279A (en) 2012-05-16
CA2764841A1 (en) 2010-12-23
US20100324599A1 (en) 2010-12-23
US9510862B2 (en) 2016-12-06

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